<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20160528028120N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-19</date_registration>
      <primary_sponsor>Isfahan university of medical sciences; research assistant part</primary_sponsor>
      <public_title>Symbiotic and blood uremic toxins in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Gasttro-Resistant Capsules of synbiotic Reduced blood uremic toxins in hemodialysis patients: double-blind placebo-controlled randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22881</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Dual block                                                                                                                                           Subjects will randomly allocated to block 1 and block 2 with the use of stratif block randomization according to gender, age (± 5 years) and hemodialysis duration (± 6 months), Blinding description: double-blind
To conduct the study in a double-blinded nature, the placebo and synbiotic capsules will encode as A and B, respectively, by a third person and patients and investigators will blind about the arms of the study.</study_design>
      <phase>2</phase>
      <hc_freetext>end stage renal disease.</hc_freetext>
      <i_freetext>Intervention 1: synbiotic                                                                                                                              The synbiotic capsules (GeriLact brand; ZIST TAKHMIR Company, Tehran; Iran) contained Lactobacillus casei (3.5×109CFU), Lactobacillus acidophilus (1.5×109CFU), Lactobacillus rhamnosus (3×109CFU), Lactobacillus bulgaricus (3.5×108CFU), Bifidobacterium breve (5×109CFU), Bifidobacterium longum (1×1010CFU), Streptococcus thermophiles (3.5×108CFU) as probiotic and fructooligosaccharide as prebiotic as well as lactose, magnesium stearate and talc as filling materials.During the 8-week intervention, the synbiotic group will receive 2 synbiotic capsules daily, between the main meals (500 mg per one capsule; onecapsule per time), containing 1000mgsynbiotic. Intervention 2: placebo                                                                                                                          maltodextrin (2 capsules per day; 1000mg).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all data except personal data

When:
2 year after pablication

To whom:
academic researcher

Conditions:
honest

Where to obtain:
soheila.mirzaeian@yahoo.com

How to obtain:
one week after request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Mirzaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar-Jerib Ave., Isfahan, IR Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۴۶</zip>
        <telephone>+98 31 4274 1499</telephone>
        <email>soheila.mirzaeian@nutr.mui.ac.ir</email>
        <affiliation>School of Nutrition and Food Sciences, Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hassan Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahn</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۴۶</zip>
        <telephone>+98 317922752</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>performing hemodialysis treatment 3-times per week for at least 4 hours each time,
not being pregnant or lactating
no history of active cancers (except for skin cancer)
no history of severe chronic conditions such as pulmonary, cardiovascular, and hepatic diseases
lack of gastrointestinal disorders, HIV disease, and psychiatric problems</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>those who used symbiotic, probiotic, prebiotic or antibiotics during 4 weeks preceding the study
those who used  immune suppressive medicines, and anticoagulant agents
with severe edema
addiction to alcohol or drugs abuse
did not respond to the questions honestly
and reported any side effects due to synbiotic consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I95.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypotension of hemodialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>synbiotic                                                                                                                              The synbiotic capsules (GeriLact brand; ZIST TAKHMIR Company, Tehran; Iran) contained Lactobacillus casei (3.5×109CFU), Lactobacillus acidophilus (1.5×109CFU), Lactobacillus rhamnosus (3×109CFU), Lactobacillus bulgaricus (3.5×108CFU), Bifidobacterium breve (5×109CFU), Bifidobacterium longum (1×1010CFU), Streptococcus thermophiles (3.5×108CFU) as probiotic and fructooligosaccharide as prebiotic as well as lactose, magnesium stearate and talc as filling materials.During the 8-week intervention, the synbiotic group will receive 2 synbiotic capsules daily, between the main meals (500 mg per one capsule; onecapsule per time), containing 1000mgsynbiotic</i_keyword>
      <i_keyword>placebo                                                                                                                          maltodextrin (2 capsules per day; 1000mg).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Indoxyl sulfate. Timepoint: 1 and 8 weeks of treatment. Method of measurement: Eliza kit.</prim_outcome>
      <prim_outcome>Crp. Timepoint: 1 and 8 weeks of treatment. Method of measurement: Eliza kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Phenol. Timepoint: 1 and 8 weeks of treatment. Method of measurement: hplc.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Food Safety Research Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Isfahan university of medical sciences; research assistant part</source_name>
      <source_name>Food Safety Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-15</approval_date>
        <contact_name>Ethics committee of Isfahan University Of Medical Sciences</contact_name>
        <contact_address>International Bureau, Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461 Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
